Observational study on ruxolitinib for myelofibrosis patients
Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
This study looks at how well ruxolitinib works for people with myelofibrosis and how different factors affect their long-term survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1055 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | ruxolitinib |
| Locations | 26 sites (Cosenza, Calabria and 25 other locations) |
| Trial ID | NCT06516406 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study examines patients with primary or secondary myelofibrosis who have started treatment with ruxolitinib as part of their standard care. It aims to assess how clinical and laboratory characteristics influence the long-term survival of these patients. Data will be collected retrospectively and prospectively, including systemic symptoms and splenomegaly assessments, over a minimum observation period of three months and a total study duration of ten years.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with primary myelofibrosis or secondary myelofibrosis related to essential thrombocythemia or polycythemia vera who are receiving ruxolitinib therapy.
Not a fit: Patients who are not receiving ruxolitinib or those with other forms of myelofibrosis not related to the specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the prognosis of myelofibrosis patients treated with ruxolitinib, potentially improving patient management and outcomes.
How similar studies have performed: Other studies have shown promising results with ruxolitinib in treating myelofibrosis, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice. * Availability of data on clinical history prior to initiation of Ruxolitinib therapy * Obtaining informed consent for data collection and processing Exclusion Criteria: * None
Where this trial is running
Cosenza, Calabria and 25 other locations
- Azienda Ospedaliera Annunziata — Cosenza, Calabria, Italy (Recruiting)
- Grande Ospedale Metropolitano "Bianchi Melacrino Morelli" — Reggio Calabria, Calabria, Italy (Recruiting)
- Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo — Naples, Campania, Italy (Recruiting)
- IRCCS Policlinico Sant'Orsola — Bologna, Emilia-Romagna, Italy (Recruiting)
- Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna — Ferrara, Emilia-Romagna, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Emilia-Romagna, Italy (Recruiting)
- AUSL di Piacenza - Palazzine Medicine Specialistiche — Piacenza, Emilia-Romagna, Italy (Recruiting)
- Dipartimento Oncoematologico - AUSL della Romagna — Ravenna, Emilia-Romagna, Italy (Recruiting)
- Ospedale Infermi di Rimini — Rimini, Emilia-Romagna, Italy (Recruiting)
- A.O.U. Integrata di Udine — Udine, Friuli Venezia Giulia, Italy (Recruiting)
- A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza" — Rome, Lazio, Italy (Recruiting)
- Ospedale S. Eugenio — Rome, Lazio, Italy (Recruiting)
- Ospedale Belcolle — Viterbo, Lazio, Italy (Recruiting)
- IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST — Genoa, Liguria, Italy (Recruiting)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy (Recruiting)
- Ospedale San Gerardo — Monza, Lombardy, Italy (Recruiting)
- Ospedale San Luigi Gonzaga - Regione Gonzole — Turin, Piedmont, Italy (Recruiting)
- Department of Oncology, University of Torino — Turin, Piedmont, Italy (Recruiting)
- Città della Salute e della Scienza — Turin, Piedmont, Italy (Recruiting)
- A. O. Ordine Mauriziano di Torino — Turin, Piedmont, Italy (Recruiting)
- Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari — Cagliari, Sardinia, Italy (Recruiting)
- A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto — Catania, Sicily, Italy (Recruiting)
- A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore — Pesaro, The Marches, Italy (Recruiting)
- Policlinico S.Maria alle Scotte — Siena, Tuscany, Italy (Recruiting)
- AOU di Padova — Padova, Veneto, Italy (Recruiting)
- A.O.U. Integrata Verona — Verona, Veneto, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Palandri, MD, PhD
- Email: francesca.palandri@unibo.it
- Phone: +390512143044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.